BIOSAFETY ACT 2007

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Oct 23, 2013 (3 years and 9 months ago)

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NBB/N/CU/10
/FORM E



1



NBB REF.NO :

(For
Office U
se
)


BIOSAFETY ACT 2007


BIOSAFETY REGULATIONS 2010


NBB/N/CU/10
/
FORM E


NOTIFICATION FOR CONTAINED USE AND IMPORT FOR CONTAINED USE ACTIVITIES
INVOLVING LIVING MODI
F
IED ORGANISM

(LMO) F
OR
BIOSAFETY LEVELS
1, 2, 3 AND 4


NBB/N/CU/10
/FORM E

shall be s
ub
mitted
to the
Director General
as

a
notification for contained use
and import for contained use

(not involving
release into the environment

of
L
iving
M
odified
O
rganism
(LMO)

as specified in Second Schedule of the Act
)
.
Any organization undertaking modern
biotechnology research and de
velopment shall

submit the notification

through its
Institutional Biosafety
Committee (IBC) that is
registered

with the National Biosafety Board
(NBB)
. The IBC should
do an
assess
ment prior

to submission.

Not all parts in
this form
will apply to every case. Therefore,
applicants will only address the specific questions/parameters that are appropriate to individual
applications.



In each case where it is not technically possible or it does not appear necessary to give the
information, the reasons shall be stated. The risk assessment, risk management plan, emergency
response plan and the fulfillment of any other requirements under t
he Biosafety Act 2007 will be the
basis of the
decision
b
y the NBB
.


The applicant shall submit 1 original and
6

copies of the notification to the Director General.

A soft
copy of the submitted
notification
(including all supporting docum
ents/attachments,

if any) shall

also be
provided in the form of a CD

by the applicant
. However, all information that has been declared as
Confidential Business Information

(CBI)

should be omitted from the CD








NBB/N/CU/10
/FORM E



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NBB REF.NO :

(For
Office U
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)

Providing information

The information provided in this
notification will be used to evaluate the emergency response plan as
specified in section 37 of the Biosafety Act 2007 and specific measures to be taken in relation to a
contained use activity involving LMO. Thus it is important to provide accurate and tim
ely information
that is as comprehensive as existing scientific knowledge would permit, and supported by whatever
data available.


The
NBB

may require additional information, and the applicant will be notified should this be the case.
If
the

applicant fail
s to provide the additional information requested, the
notification
shall be deemed to
have been withdrawn but it shall not affect the right of the applicant to make a fresh
notification.


Accuracy of information

The notification should also be carefully c
hecked before submission to ensure that all the information
is accurate. If the information provided is incorrect
,
incomplete

or misleading,
the NBB may issue a
withdrawal of the acknowledgement of
receipt
of notification without prejudice to the submissio
n of a
fresh notification


Confidentiality

Any information within this notification which is to be treated as CBI, as described in the Biosafety Act
2007 in section 59(3) should be clearly marked “CBI” in the relevant parts of the notification

by
providing

the justification for the request for CBI
.
The following information shall not be considered
confidential:

a)

The na
me and address of the applicant

b)

A general description
of the
LMO

c)


A summary of the risk assessment of the effects on the conservation and sustainable


use of biological diversity, taking also into account risks to human health; and

d)

Any methods and plans for emergency response


A
uthoriz
ation

Please ensure that if this

no
tification

is being completed on behalf of the proposed user, that the
pe
rson completing this notification

holds p
roper authority to submit this notification

for the proposed
user.
Please provide written proof of authorization.





NBB/N/CU/10
/FORM E



3



NBB REF.NO :

(For
Office U
se
)

For further information

Please contact the Director General

by:

Telephone:

603
-
8886 1579


E
-
mail: biosafety@nre.gov.my




The completed form
s

to be submitted as follows:

The Director General


Department of Biosafety

Ministry of Natural Resources and Environment Malaysia

Level 1
,

Podium
2

Wisma Sumber Asli, No. 25, Persiaran Perdana

Precinct 4, Federal Government Administrative Centre

62574
P
utrajaya
,
Malaysia
.


Acknowledgment
o
f Receipt

Upon receipt of the
notification,
the Director General shall send to the applicant an
acknowledgement
of receipt with an assigned reference number. T
he reference number should be used in all
correspondence with respect to the notification.



Exemption

The First Schedule of the
Biosafety (Approval and Notification) Regulations 2010 allow
s

exemptions
for some types of
t
echniques

and contained use activities in relation to LMO posing a very low risk (i.e.
contained research

activities

involving very well understood organisms and processes for creating and
studying
L
MO)
. Exempted
activities

s
hould be carried out under conditions of standard laboratory
practice.

A
ppropriate

biosafety levels
as according to Second Schedule of the
Biosafety (Approval and
Notification) Regulations 2010
should be used for the exempted activities and personnel shoul
d have
appropriate training. P
rincipal Investigators

who believe that the work falls into any of the

exemptions
should nevertheless notify their IBC of the proposed project.

The IBC may
review all submitted
research projects to

determine their exemption or

non
-
exemption status
.


Please retain a copy of your completed notification.




NBB/N/CU/10
/FORM E



4



NBB REF.NO :

(For
Office U
se
)

N
otification Check List


1.

Form
NBB/N/CU/10/FORM E

is
completed

with relevant signature
s obtained



2.

Notification assessed and to be sent through the IBC

(if relevant)



3.

A copy of clearance documents from the relevant
G
overnment agencies (if
required)


4.

Any information to be treated as confidential
business
information should be
clearly marked “CBI” in the notifi
cation



5.

1
original and
6

co
pies of the complete
d

notification

submitted
. A soft copy of the
submitted notification (including all supporting documents/attachments, if any)
that do not contain any CBI.






Preliminary information

1.

Organization
:


2.

Name of Applicant:



3.

Position in Organiz
ation
:

Telephone (office)
:

Telephone (mobile)
:

Fax number
:

Email
:

Postal Address
:




4.

Project Title:


5.

IBC
Project Identification No:




6.

Is this the first time the activity
is being notified?



Yes


No If no, please provide information in number
7



NBB/N/CU/10
/FORM E



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NBB REF.NO :

(For
Office U
se
)


7.

I
) Please provide the
NBB

reference number of your
previous notification.



II
) How is this

notification
different from the previous
notification submitted for this
activity?

(please provide an
attachment if additional space
is required)





Details
of

Agent / Importer


8.
Organization:



9.
Contact Person:



10.
Position in Organization
:

Telephone (office)
:

Telephone (mobile)
:

Fax number
:

Email
:

Postal Address
:











NBB/N/CU/10
/FORM E



6



NBB REF.NO :

(For
Office U
se
)


Institutional Biosafety Committee (IBC) Assessment Report for the contained use and import for

contained use of LMO


This must be completed by the
registered
IBC
of

the Applicant
’s

o
rganization


Section A


IBC Details

1

Name of
or
ganization:
:


2

Name of IBC
Chairperson:



Telephone
number:


Fax:



Email address:



Section B


IBC Assessment

3

Name of principal
investigator:


4

Project Title:


5

Date of the IBC

Assessment:


6

Does the IBC consider that the
principal investigator and every
other person(s) authorized
to be involved in contained use of the
LMO have adequate training and experience for the task?



Yes

No

7

The following information related to this project has been checked and approved

a)


The objective of the project


Yes

No

b)


The description and genetics of the LMO



Yes

No

c)

The emergency response plan and the specific measures to be
taken in relation to a contained use activity involving LMO.


Yes

No

NBB/N/CU/10
/FORM E



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NBB REF.NO :

(For
Office U
se
)

8

Has the information been checked by the IBC and found to be complete?



Yes

No

9

Has the IBC assessed the biosafety of the proposed project?


Yes

No

If yes, please append a copy of the IBC’s assessment report and indicate the attachment

in which
details are provided.


Signatures and Statutory Declaration

The contained use of LMO within this project has been assessed a
s above and endorsed by the IBC.
We declare that all information and documents herein is true and correct. We understand
that
providing misleading information to the NBB, deliberately or otherwise, is an offence under the
Biosafety Act 2007.


Applicant:


Signature: ______________________ Date: ______________________________


Name as in Identity Card/Passport: ______________
________________________


Official Stamp:


IBC Chairperson
:


Signature: ______________________ Date: ______________________________


Name as in Identity Card/Passport: ______________________________________


Official Stamp:


Head of organization/
Authori
zed

representative
:


Signature: ______________________ Date: ______________________________


Name as in Identity Card/Passport: ______________________________________

Official Stamp:


NBB/N/CU/10
/FORM E



8



NBB REF.NO :

(For
Office U
se
)



Part A General Information


A1 Information

1.

The name and address

of the applicant and the name, qualifications and experience of the
scientist and of every other person who will be responsible for planning and carrying out the
contained use activities and for the supervision, monitoring and safety of the activity.


A2
Project Introduction


In this Part, the applicant is required to describe the proposed activities with the LMO within the
context of the project.


2.

Project Title:


3.

Biosafety Level (BSL)
:



BSL

1




BSL
2



BSL
3



BSL
4




4.

Rationale of
activity:


5.

Overall Project/Programme Objective:

Specific Objective(s)
:


6.

Include an estimated time sch
edule to achieve the objectives:


7.

Intended Date of Commencement:


8.

Expected Date of Completion:


9.

For an imported LMO


the date of importation or intended importation, including, if possible, a
copy of documentation of clearance or assessment from the relevant authorities like
Department
of Agriculture (
DOA
)
, Ministry of Health, Malaysia
, etc.
.
.


NBB/N/CU/10
/FORM E



9



NBB REF.NO :

(For
Office U
se
)

10.

Categories of people
(Research staff, technicians, students etc) authorised to under
take
activities with the LMO:


11.

Briefly describe the pr
oject using non
-
technical terms:


12.

If the experiments are successful are there plans for an application for field experiment?

Yes


No



13.

If yes, where would the proposed field experiment take place?


14.

Who will undertake the unconfined release?




A3 Description of the LMO


The information requested in the following section is required to help identify any possible hazards
associated with
the proposed activities with the LMO
. S
ome

questions in this section may also relate
to risk assessment and risk management, which are addressed in A4.

(
If more than one
LMO is
involved, then the information required in
A3
should be repeated for each

LMO)
.








NBB/N/CU/10
/FORM E



9



NBB REF.NO :

(For
Office U
se
)

Please fill the specific information in a tabulated form as below


Table
1

Description of the LMO for contained use activities


LMO

Common

and
scientific

name of donor
organism

Common and
s
cientific
name of

parent
organism

Vector(s) or
method of
genetic
modification

Class of
modified trait
(
R
efer to
Box

1
)

Modified
trait

Identity a
nd
function of
gene(s)of donor
organism
responsible for
the modified trait

Target
organism
(
s
)
of the LMO


Target

tissue
s

for
genetic
modification

1

















2

















NBB/N/CU/10
/FORM E



10



NBB REF.NO :

(For
Office U
se
)


Box

1 :

Various
Classes or Types of Traits


NO

Class

(type) of trait

1

Abiotic stress resistance

2

Altered agronomic characteristics

3

Altered nutritional characteristics

4

Altered pharmaceutical characteristics

5

Altered physical product characteristics

6

Antibiotic resistance

7

Foreign antigen expression

8

Attenuation

9

Bacterial resistance

10

Disease resistance

11

Flower colour

12

Fungal resistance

13

Herbicide tolerance

14

Immuno
-
modulatory protein expression

15

Pest resistance
e.g.

insect

16

Protein expression

17

Reporter/marker gene expression

18

Virus resistance

19

Other (provide details)

20

Unknown


NOTE:

1.

If the LMO has more than one modified trait please list all, as according to the list in the Box 1.

2.

If the modified trait is not listed in the Box 1, please list it as “other” and
provide details of the
modified trait.



NBB/N/CU/09/FORM E



11



NBB REF.NO :

(For Office Use)

A4 Risk assessment and management

(
If more than one
LMO is
involved, then the information required in
A4.1, A4.2 & A4.3 should be
repeated for each
LMO)


In order to
prepare

the Emergency Response Plan, a
n assessment of any
possible risks or
potential harm that may be posed by the LMO and the level of risk posed by such hazards based
on an assessment of the likelihood and consequence of the hazard occurring

must be carried out.

The risks that the IBC is required to assess are:

a)

risks to the health and safety of humans from the activities assoc
iated with genetic
modification

b)

risks to the health and safety of humans from an unintentional release of the LMO; an
d

c)

risks to the environment from an unintentional release of the LMO


The risk management plan details how any risks posed by the LMO will be managed to ensure
that unacceptable risks are not realised.


Summaries of any protocols and/or standard operating
procedures can be included to specifically
answer the individual questions.


A4.1 Risk Assessment (Basic information)


15.

Is there any risk to health and safety of humans occurring from the proposed activity

over and
above those posed by the donor
/parent

orga
nism
?


No known hazard




Not relevant





Yes



If yes, please provide information in question below
.


16.

What are the possible hazard(s) and the likelihood and consequence of the hazard(s)
occurring (
i.e.

the risk) from the proposed genetic modification(s)?


17.

In regard to the health and safety of humans, what are the possible hazard(s) and the
likelihood and consequence of the hazard(s) occurring (
i.e
.

the risk) from an unintentional
release of the LMO into

the environment?


18.

In regard to the environment, what are the possible hazard(s) and the likelihood and
consequence of the hazard(s) occurring (
i.e.

the risk) from an unintentional release of the
LMO

into the environment?


NBB/N/CU/09/FORM E



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NBB REF.NO :

(For Office Use)

A4.2 Risk Management


19.

Do you prop
ose to transport the LMO outside the premises?

If yes, describe the precautions
taken.


20.

How will the LMO be disposed of?


21.

What are the procedures for decontaminating equipments used during the proposed activities
in order to render any LMO unviable?


A4.3 Emergency Response Plan

22.

Plans for protecting human health and the environment in case of the occurrence of an
undesirable effect

observed during contained use activities
.

23.


Methods for removal of the LMO in the affected areas

in the case of an uninten
tional release
.

2
4
.

Methods for disposal of other plants, animals and any other organisms

exposed during
the
u
nintentional release
.

2
5
.

M
ethods for isolation of the area affected by the unintentional release
.

2
6
.


Details of any other contingency measure

that will be in place to rectify any unintended
consequences if an adverse effect becomes evident during the
contained

use activities or
when an unintentional release occurs.


















NBB/N/CU/09/FORM E



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NBB REF.NO :

(For Office Use)

A5 The Premises


Please provide information for all of the facilities being used for the confined activities in the table below.

Information required

Premise 1

Premise 2*

Premise 3*

1.
Name of premises:





2.
Premises type:

(e.g. animal
containment premise,
laboratory, insect containment premise, etc)





3.
Biosafety
level

(BSL)
:





4.
Who undertook the inspection:

(indicate whether it was
NBB
,
IBC

or its
representative)





5.
Date of most
-
recent inspection
:





6.
Fill the following
if the BSL level is 3 or 4:


Date of certification by competent authority
(If any)


Certificate reference no
:





NBB/N/CU/09/FORM E



14



NBB REF.NO :

(For Office Use)

7.
Premises address
:









8.
Premises contact person details/ Biosafety
Officer

Name:





9.
Business phone number:





10.
Mobile phone
number:





11.
Fax number:





12.
Email address:






Note:

* For notifications with more than one premise; use additional columns if necessary.


A6. Confidential Business Information


Enter in this section any information required in Part A

1
-

A 5 for which confidentiality is claimed together with full justification for that claim.


NBB/N/CU/09/FORM E



15



NBB REF.NO :

(For Office Use)